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What (Now!) If I'm Doing Exempt or Non-exempt Recombinant DNA (rDNA) Experiments?

Facts

• If you will be working with rDNA and funded by NIH or working at an Institution where work involving rDNA is funded by NIH (like it is at the UConn Health Center), you are working under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH rDNA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rDNA at the whole institution.
   
• Institutions (the UConn Health Center), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rDNA Guidelines.
   
• To familiarize yourself with the NIH rDNA Guidelines, read The Guidelines Explained (PDF). Relative to the real thing, it's short and sweet. (not complete, but it covers a lot.)
   
• Many rDNA experiments are exempt (PDF) to the NIH Guidelines, but some that you might think are exempt may not be. Experiments that are not exempt need to be registered with the IBC before they are started. In some cases the application needs only to be submitted and accepted by the IBC before work may start.
   
• Viral Vector rDNA experiments need to be registered with the IBC.

Strategy (What to Do)

• Determine if your experiment or set of experiments is exempt or not exempt.
   
• If you know your experiment(s) is not exempt go to the IBC Forms page and fill out the appropriate one step process form.
   
• With regard to an experiment being exempt, the only way for a PI to be sure they have done all they can to ensure their compliance with the NIH rDNA Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, the IBC Coordinator may serve as the IBC's proxy to make this determination and perform the documentation. This makes the decision about whether an experiment needs to be registered or not, quicker and not too hard. The IBC Coordinator then brings such determinations to the IBC for review.
   
• If you believe your experiment(s) is exempt, start the two step registration process by filling out IBC Form A (Word doc). There are two possible outcomes:
  • Your experiment(s) is determined to be exempt. In this case, there is no more to do, your experiment has been documented and given an IBC number, or;
  • Your experiment(s) is determined to be not exempt. In this case, fill out IBC Form B (Word doc) and submit both forms A and B to the IBC coordinator for an IBC review.
     
• If you have determined that your experiment(s) is exempt, but there is no documentation, please fill out IBC Form A (Word doc) and submit it to the IBC Coordinator.